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Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

5

Completion Date

April 2011

Primary Completion Date

April 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Female, aged 18 years or older and able to give informed consent.

Histologically- or cytologically-proven adenocarcinoma of the breast at time of first diagnosis

ECOG performance status 0 or 1

Life expectancy > 12 weeks

Stage IV disease and have at least one lesion measurable by standard RECIST criteria

Disease progression after at least one prior chemotherapy regimen for metastatic disease or within 12 months of adjuvant chemotherapy initiation.

All chemotherapy must be stopped > 2 weeks before enrollment.

Primary or metastatic tumor must be negative for estrogen and progesterone receptor expression. Testing must be done in a CLIA-approved laboratory.

Primary or metastatic tumor must have 0 or 1+ staining for HER2/neu identified immunohistochemically (IHC), by an approved method using one of the standard monoclonal or polyclonal antibodies (HercepTest, cb-11, PAb1, or TAB250), or if FISH status is known, it must be negative. Testing must be done in a CLIA-approved laboratory.

Left ventricular ejection fraction must be >= institutional lower limit of normal as determined by MUGA or echocardiogram

Patient must be able to comply with treatment and follow-up procedures:

If female is of childbearing potential, pregnancy test must be negative and patient must be willing to use effective contraception while on treatment and for at least 3 months after the last dose of study medication

Exclusion Criteria:

Prior treatment with VEGF targeted therapy

Prior taxane therapy for metastatic disease or for adjuvant therapy within the previous 12 months

History of prior cancer, excluding carcinoma in situ of the cervix and non-melanoma skin cancers

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study

Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment

History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment

Serious, non-healing wound, ulcer or bone fracture

Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC) ratio >1.0 at screening OR Urine dipstick for proteinuria >2+ (patients discovered to have >2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate <1g of protein in 24 hours to be eligible)